A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Tuesday, 5 November 2013

The SPC Blog has received a cheerful note from Mike Snodin (who now heads Pharma & Nutrition at Avidity IP). What brings such good cheer? Mike has been working hard to talk the UK Intellectual Property Office round to his point of view, with some success. Writes Mike:

By way of a decision issued on 22 October
2013 (BL O/418/13), the hearing officer, Dr Lawrence Cullen, essentially agreed
with Mike’s arguments that:

(i)
Article 3(b) of Regulation 469/2009 requires there to be a valid
Marketing Authorisation (MA) in force;

(ii)
following the CJEU’s decision in Case C-127/00 (Hässle AB), Article 13(1) must be
interpreted as referring to the same type of MA as Article 3(b) (i.e. a valid
MA); and

(iii)
for a “centralised” MA (from the European Commission / EMA) the earliest date
that the MA becomes valid is the date of notification of the
European Commission’s decision to the applicant.

This development follows similar arguments
first proposed by Mike in his October 2011 article in SCRIP Regulatory
Affairs (as reported here
in this blog).

Longer SPC Term

As a result of the decision, longer term
should now be available in the UK for those SPCs where:

(a)
the earliest marketing authorisation (MA) in the European Economic Area is a
“centralised” MA issued by the European Commission (EC); and

(b)
less than 10 years have elapsed between the filing of the basic patent and the
date of the EC’s decision to grant a MA.

The number of SPCs potentially affected is
significant. For example, longer exclusivity could now be available for
over 140 human or veterinary medicinal products. Further, the percentage
of SPCs that could benefit from longer term appears to have significantly
increased in recent years. For example, for SPCs filed to date in the UK
in 2013, over 40% could gain additional days of term.

For affected SPCs, the additional term that
will now be obtainable in the UK is typically in the region of 2 to 4
days. However, research conducted by Mike has identified numerous
examples of SPCs in the UK for which the additional term would be longer than
this, even in excess of 1 week (or, in one instance, in excess of 2 weeks).

At least for granted SPCs, positive action by
proprietors will be necessary in order for them to benefit from the additional
term now available.

Implications for filing deadline

Where the MA for the UK is a “centralised” MA,
the deadline mentioned in Article 7(1) should now be interpreted as meaning 6
months from the date of notification of the “centralised” MA. This (later) deadline ought not to be relied upon outside of the UK unless and
until practice of the national patent offices becomes completely harmonised on
this point.

Euratom

As an aside, Mike advises that he personally has not given up on trying to persuade patent offices such as the UK IPO to
accept further arguments based upon provisions of the Euratom treaty - though
such arguments were not accepted on this occasion. If they had been, they
could have provided an additional day of SPC term for almost all UK SPCs where
(a) and (b) above are true.

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann-Eitle have generously provided a copy of a recent decision of the Higher Regional Court o...

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